510(k) · Cleared
ClearedCrystal and Crystal-Care Implants System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crystal-Seal Dental Implants · DZE Implant, Endosseous, Root-Form
Cleared on Oct 22, 2001 after a 159-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Oct 22, 2001
- Review
- 159 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK011502 Crystal and Crystal-Care Implants SystemCrystal-Seal Dental Implants · 2001
- Descendant · cites it directly · 5 of its ownK033392 Immediate Stabilizing Implant (Isi)O Co., Inc. · 2003
- Descendant · 2 generations on · 4 of its ownK090174 Tsi; EriOco Biomedical · 2009
- Descendant · 2 generations on · 1 of its ownK110337 Universal Maxillary MolarOco Biomedical · 2012
- Descendant · 3 generations on · 0 of its ownK171197 Zuga Dental Implant SystemZuga Medical, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK142846 BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc. · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K033392Immediate Stabilizing Implant (Isi)O Co., Inc. · 2003 · cites it directly5descendants
- K090174Tsi; EriOco Biomedical · 2009 · 2 generations on4descendants
- K110337Universal Maxillary MolarOco Biomedical · 2012 · 2 generations on1descendant
- K171197Zuga Dental Implant SystemZuga Medical, Inc. · 2018 · 3 generations on0descendants
- K142846BBX1, BBX2, BBX1MO, BBX1MCGlobaldental, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011502 | Crystal and Crystal-Care Implants System | Crystal-Seal Dental Implants | 2001 | — |
| +1 | K033392 | Immediate Stabilizing Implant (Isi) | O Co., Inc. | 2003 | — |
| +2 | K090174 | Tsi; Eri | Oco Biomedical | 2009 | — |
| +2 | K110337 | Universal Maxillary Molar | Oco Biomedical | 2012 | — |
| +3 | K171197 | Zuga Dental Implant System | Zuga Medical, Inc. | 2018 | — |
| +2 | K142846 | BBX1, BBX2, BBX1MO, BBX1MC | Globaldental, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033392 (O Co., Inc., 2003) has gone furthest, with 5 descendants of its own.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
https://510kreport.com/device/K011502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011502: Crystal and Crystal-Care Implants System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011502
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026